A Study to Learn About the Study Medicine Called PF-07054894 in People of Japanese Origin

Healthy Clinical Trial

Official title:

A PHASE 1, RANDOMIZED, DOUBLE BLIND, SPONSOR OPEN, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE ORAL DOSES OF PF-07054894 IN HEALTHY ADULT JAPANESE PARTICIPANTS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06327880
• Other study ID #: C4151006
• Secondary ID: 2023-509339-17-0
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 13, 2024
• Est. completion date: July 2, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants. The study is seeking the following participants: - Male or female Japanese participants aged 18 years or older. The participants should be healthy after going through some medical tests. - Have a Body Mass Index (BMI) of 16 to 32 kilogram per meter squared; and a total body weight of more than 45 kilograms (100 pounds). - Are willing and able to follow all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: July 2, 2024
• Est. primary completion date: July 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy male and female Japanese subjects aged 18 years or older
• Body Mass Index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (100 lb)

Exclusion Criteria:

• Evidence or history of clinically significant disease or medical conditions
• Positive urine drug test or history of alcohol abuse or illicit drug use.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-07054894 or placebo
multiple oral doses of PF-07054894 for 14 days

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit - Brussels	Brussels	Bruxelles-capitale, Région DE

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AE) or serious adverse events (SAE)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs.	Screening, Baseline through study completion, an average of 11 weeks
Primary	Number of participants with clinically meaningful change from baseline in laboratory tests results		Screening, Baseline, Day 2, 7 and 14
Primary	Number of participants with clinically meaningful change from baseline in vital signs	Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate	Screening, Day 1, 2, 7, 14, and 15
Primary	Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters		Screening, Day 1, 2, 7, 14 and 15
Primary	Maximal plasma concentration (Cmax)	The maximum observed plasma concentration (Cmax) will be observed directly from data.	Day 1 and 14
Primary	Time to Maximum Plasma Concentration (Tmax)	Tmax will be observed directly from data	Day 1 and 14
Primary	Area Under the Plasma Concentration-Time Profile From Time Zero (AUCt) To End of Dosing Interval (AUCt)	AUCt is summarized by dosing interval and day. Dosing interval is the interval t between administration of doses of drug.	Day 1 and 14
Primary	Half-life of PF-07054894	terminal elimination half-life will be calculated based on the measured data	Day 14
Secondary	Observed Accumulation Ratio (Rac)	Rac is calculated as, area under the curve from time zero to end of dosing interval on Day 14 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1 (AUCt)	Day 14
Secondary	Observed Accumulation Ratio Based on Cmax (Rac,Cmax)	Rac Cmax is calculated as, maximum observed plasma concentration on Day 14 (Cmax) divided by maximum observed plasma concentration on Day 1 (Cmax)	Day 14
Secondary	Trough plasma concentrations (Ctrough)		Day 14
Secondary	Apparent Volume of Distribution (Vz/F) as data permits	Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. VZ/F after oral dose is influenced by the fraction absorbed.	Day 14
Secondary	Apparent Oral Clearance (CL/F)	CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes	Day 14

External Links

•   To obtain contact information for a study center near you, click here.